LEGAL UPDATES BY BEPARTNERS
Health & Pharmaceuticals
Introduction to New Cosmetics Notification Procedures
25 July 2020

In order to support the continuous demand of cosmetics and ensure the development of the cosmetics industry in Indonesia, the National Agency for Drug and Food Control or locally known as Badan Pengawas Obat dan Makanan - “BPOM”, has issued BPOM Regulation No. 12 of 2020 concerning Procedures for the Submission of Cosmetics Notifications (“BPOM 12/2020”). This replaces the Regulation of the Head of the BPOM No. HK.03.1.23.12.10.11983 of 2010 concerning Criteria and Procedures for Cosmetics Notification Applications, which was amended once through the issuance of Regulation No. 34 of 2013.

 

The objectives of officially ratifying BPOM Regulation 12/2020 is to ensure the fulfillment of cosmetic producers in their compliance with various criteria relating to safety, purpose, quality, designation and manufacturers’ claims in order to ensure the cosmetics industry’s consistency throughout Indonesia. In order to fulfill the criteria this would entail ensuring that all necessary documentation is submitted including the Product Information Document/Dokumen Informasi Produk – “DIP[1]. Prior to legally distribute cosmetics within Indonesia, the applicant would need to hold an official distribution license (“Notifications”).

 

In light of the above, BPOM Regulation 12/2020 has now further clarified in identifying which applicants are required to conduct the Notifications application as per the relevant criteria and requirements (“Applicants”). The Applicants are categorized as below:

 

  1. Cosmetics industry located in Indonesian jurisdiction;
  2. Individual/corporate businesses in cosmetics industry that are bound to production contracts with the Cosmetics industry in Indonesian jurisdiction;
  3. Importers of cosmetics.

 

Furthermore, each Applicant has individual mandatory documentation that are required to be fulfilled and submitted in order to continue process of Notifications, including but not limited to (i) Business Identification Number; (ii) Copy of Identity Card/other relevant document; (iii) Copy of Certificate of Good Manufacturing Practice for Cosmetics; (iv) Statement letter that stating the organs of cosmetics company never been involved in any criminal acts within the cosmetic sector; (v) Recommendations letter issued by Head of the BPOM’s Technical Implementation Unit; (vi) Copy of relevant business license; (vii) Copy of cooperation agreement in cosmetic industry; (viii) Copy of valid agency appointment letter.

 

The first stage of procedures of Notifications is selecting and submitting certain documents that have been adjusted to the Applicant criteria. After such, the Applicant would be required to submit the documents using the Notifications template electronically via the official BPOM Cosmetics Notification Service website (“Website”). The Applicant will then receive an Electronic Payment Order/Surat Perintah Bayar – “SPB” electronically and will be required to further follow instructions to obtain the Notification. The flowchart below are specific procedures of submission of the cosmetics notifications:

 

 

 

BPOM Regulation 12/2020 also stipulates administrative sanctions if the Applicant fails to follow the applicable provisions, such as (i) Notifications Procedures, (ii) Notifications Criteria and Requirement, and (iii) Notifications Update and Changes. Sanctions will be issued accordingly as the following:

  1. written warnings;
  2. revocation of notifications;
  3. blocking of online access for submission of notification application for a maximum of 1 (one) year; and/or
  4. blocking of online access for submission of application for import certificate for a maximum of 1 (one) year.

 

If there are any queries with regards to how this may affect your business, please contact us for further legal consultation.

 

This information does not, and is not intended to, constitute as legal advice; instead, all information, content, and materials are for general information only.

 

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[1] DIP is required before submitting a Notification application as per Article 3(2) of BPOM No.12/2020.

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